An Observational Registry of Chinese COPD Study

NCT04318912 | Not Yet Recruiting DMC

• 1 other identifier: 21971
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. The objective is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China.

Conditions

COPD

Keywords

COPD; health policy; telimedicine; management

Outcome Measures

Primary Outcomes (2)

• Characterize COPD Disease Severity in Clinical Practice

  Pulmonary Function Test measured by protable spirometer can represent the severity stages of COPD

  2 years

• Characterize COPD Disease Activity in Clinical Practice

  Acute exacerbation of symptoms can reflect the disease activity and disease control of COPD.

  2 years

Secondary Outcomes (4)

• Evaluate Medical Expenditure in Clinical Practice

  2 years

• Evaluate Patient Reported Outcome

  2 years

• Evaluate Health Related Quality of Life

  2 years

• Evaluate Digital Health Technology Outcome

  2 years

Study Arms (1)

COPD patients

Adults age 40 or older with a diagnosis of chronic obstructive pulmonary disease (COPD) having been prescribed any COPD treatment (initial or subsequent) outside of a clinical trial.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults age 40 or older with COPD having been prescribed any COPD treatment outside of a clinical trial. 3000-5000 patients are planned to be recruited.

You may qualify if:

• Adults age 40 or older with a diagnosis of chronic obstructive pulmonary disease (COPD) having been prescribed any COPD treatment (initial or subsequent) outside of a clinical trial.
• Have plans for future visits at the site for continued management of COPD.

You may not qualify if:

• Inability to provide written informed consent/assent.
• Being enrolled in any interventional study or trial for COPD treatment. Note: Patient may be enrolled in other registries or studies where COPD treatment outcomes are observed and/or reported (such as center-based registries).

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Related Publications (2)

• Tang X, Pan J, Fang F, Li Y, Lei J, Niu H, Li W, Dong F, Zheng Z, Peng Y, Yang T, Wang C, Jia C, Huang K. Characteristics and risk factors of patients with undiagnosed COPD in China: results of a nationwide study from the 'Happy Breathing' Programme with mixed methods evaluation. BMJ Health Care Inform. 2025 Oct 7;32(1):e101323. doi: 10.1136/bmjhci-2024-101323.

  PMID: 41057271 DERIVED

• Jia C, Zhang C, Fang F, Huang K, Dong F, Gu X, Niu H, Li S, Wang C, Yang T. Enjoying Breathing Program: A National Prospective Study Protocol to Improve Chronic Obstructive Pulmonary Disease Management in Chinese Primary Health Care. Int J Chron Obstruct Pulmon Dis. 2020 Sep 15;15:2179-2187. doi: 10.2147/COPD.S258479. eCollection 2020.

  PMID: 32982210 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chen Wang

  China-Japan Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

Ting Yang

CONTACT

+861084206276; dryangting@qq.com

Shiyi Gong

CONTACT

+8618813185680; gongshiyi1995@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 24, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2022
• Study Completion (Estimated): May 1, 2030
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share